Senior Clinical Research Associate - Oncology | Remote

Parexel; Topeka (KS); Remote; USD 75,000 - 110,000; Full time

Job summary

Parexel is seeking an experienced Clinical Site Monitor to oversee site activation through database lock for Oncology and Non-Oncology trials in the United States. You will ensure adherence to SMP, GCP, and client standards while coordinating with SCP and the study team.

You will travel 60–80% to investigator sites, provide training, perform on-site and remote monitoring, and support recruitment initiatives.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• Monitoring experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology).
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

Responsibilities

• Ensure proper conduct of clinical trials in accordance with the SMP and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or explode to the SCP to ensure quality of site delivery
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
• Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required
• Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, SOPs
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
• Submit all required reports, documentation, updates and tracking within required timeframes, including TMF documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics

Skills

ICH/GCP knowledge

Clinical monitoring

Oncology experience

Global trials

English fluency

Travel readiness

Education

Bachelor's degree in life sciences

Job description

Parexel is seeking an experienced Clinical Site Monitor to oversee site activation through database lock for Oncology and Non-Oncology trials in the United States. You will ensure adherence to SMP, GCP, and client standards while coordinating with SCP and the study team.

You will travel 60–80% to investigator sites, provide training, perform on-site and remote monitoring, and support recruitment initiatives.